Actively Recruiting
CorWave LVAS FIH Study
Led by CorWave · Updated on 2026-02-09
20
Participants Needed
2
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and effectiveness of the CorWave LVAS for the treatment of advanced heart failure patients.
CONDITIONS
Official Title
CorWave LVAS FIH Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or legal representative has signed Informed Consent Form
- Age greater than 18 and less than 75 years old
- Body Surface Area (BSA) of at least 1.2 m2
- Left Ventricular Ejection Fraction (LVEF) of 35% or less
- Inotrope dependent OR Cardiac Index (CI) less than 2.2 L/min/m2 while not on inotropes and meeting one of the following:
- On Guideline Directed Medical Therapy (GDMT) for at least 45 out of the last 60 days without response
- Advanced heart failure (Class III or IV for at least 14 days) with support from short term mechanical circulatory support up to 7 days
- Females of childbearing age must agree to use adequate contraception
- Patient must be eligible for heart transplantation
You will not qualify if you...
- Heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
- Technical obstacles posing high surgical risk per Investigator
- Ongoing mechanical circulatory support other than IABP or micro axial pumps
- INTERMACS Class I patients
- Patient on a ventilator
- Pregnant or breastfeeding
- Presence of a mechanical aortic valve not planned for conversion to bioprosthesis at LVAD implant
- History of any organ transplant
- Platelet count below 100,000/µl
- Psychiatric disease, illicit drug use, irreversible cognitive dysfunction, or psychosocial issues impairing compliance
- History of untreated abdominal aortic aneurysm greater than 5 cm within 6 months
- Active, uncontrolled infection
- Intolerance to anticoagulant or antiplatelet therapies or required peri/post-operative therapy
- Severe end organ dysfunction or failure signs such as:
- INR 2.0 or higher not due to anticoagulation therapy
- Total bilirubin above 43 µmol/L (2.5 mg/dL), liver function tests > 3 times normal, serum albumin below 3.5 g/dl, shock liver, or liver cirrhosis
- Severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease with FEV1 less than 50%, total FEV1 below 1000 mL, and DLCO less than 50% predicted
- Fixed pulmonary hypertension with PVR 8 Wood units or higher unresponsive to treatment
- Stroke within 90 days prior or cerebrovascular disease with significant carotid stenosis
- Serum creatinine 221 µmol/L (2.5 mg/dL) or higher or need for chronic renal replacement therapy
- Ongoing malnutrition with over 5% weight loss in 30 days, low prealbumin, or poor nutritional assessment score
- Poorly controlled diabetes or hemoglobin A1c over 8.5%
- Significant peripheral vascular disease with rest pain or ulcers
- Severe aortic insufficiency without planned correction during implant
- Planned Bi-VAD support before enrollment
- Known hypo- or hypercoagulable states like disseminated intravascular coagulation or heparin induced thrombocytopenia
- Participation in other clinical studies affecting results
- Conditions other than heart failure limiting survival to less than 12 months
- Acute myocardial infarction within 14 days of implant
- Pulmonary embolus within 6 weeks of implant
- Unwillingness or inability to comply with trial requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
St Vincent's Hospital Sydney
Sydney, New South Wales, Australia, 2010
Actively Recruiting
2
Bayside Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
G
Gabriella Giaquinta
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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